PK Study of YH22162 FDC Compared to Combination of Twynsta and Hygroton

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan/Amlodipine 80/5 mg (FDC); Drug: YH22162; Drug: Chlorthalidone 25mg

• Registration Number: NCT02496910
• Lead Sponsor: Yuhan Corporation

Brief Summary

This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover design.

Detailed Description

This is a 2 by 2 cross-over study to evaluate pharmacokinetics of YH22162 FDC compared to reference twynsta and Hygroton co-administered in two groups enrolling healthy adult male subjects under fasting conditions.

Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22162 FDC or twynsta and Hygroton co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The two treatment periods will be separated by a washout period.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

Inclusion Criteria

1. Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
2. Who has not suffered from clinically significant disease
3. Provision of signed written informed consent

Exclusion Criteria

1. History of and clinically significant disease
2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
3. Administration of other investigational products within 3 months prior to the first dosing.
4. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
5. Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2 - Period 2	Chlorthalidone 25mg	Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
Group 1 - Period 1	Chlorthalidone 25mg	Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
Group 2 - Period 2	Telmisartan/Amlodipine 80/5 mg (FDC)	Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
Group 1 - Period 1	Telmisartan/Amlodipine 80/5 mg (FDC)	Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
Group 1 - Period 2	YH22162	YH22162 FDC tablet of Yuhan Corporation
Group 2 - Period 1	YH22162	YH22162 FDC tablet of Yuhan Corporation

Primary Outcome Measures

Name	Time	Method
Bioequivalence study is based on Cmax and AUC parameters	1 month

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Chunju, Korea, Republic of